A Study to Investigate Efficacy and Safety of FWY003 Compared With Placebo in Participants With Geographic Atrophy Secondary to Age-related Macular Degeneration

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age50+
SponsorNovartis Pharmaceuticals

About this trial

To characterize the dose response relationship of FWY003 in participants with geographic atrophy (GA) secondary to age-related macular degeneration (AMD).

Eligibility criteria

Qualifiers

A diagnosis of GA secondary to AMD in at least one eye (study eye). If both eyes qualify, then the eye with the better BCVA would be assigned as study eye.

Total GA area must be ≥2.5 and ≤17.5 mm2 (1 and 7 disk areas (DA), respectively)

If GA lesion is multifocal, then the total lesion area must be between 2.5-17.5 mm2 and at least one lesion should have an area of at least 1.25 mm2

Entire GA lesion must be visualized on the macula centered image and not contiguous with peripapillary atrophy

Disqualifiers

A history of, or current evidence of, choroidal neovascularization (exudative MNV) in either eye, as determined by the central reading center on multimodal imaging at screening.

Previous cell or gene therapy in either eye.

Macular atrophy in either eye due to a cause other than AMD, such as Stargardt disease, cone rod dystrophy, toxic maculopathies, etc.

Intraocular surgery, including cataract and vitreoretinal surgery, in the study eye within 3 months prior to Baseline.

Trial design

Treatments tested in this trial

  • FWY003
  • Placebo

Treatment groups

272 Participants
are divided into 4 treatment groups

Sponsors and collaborators